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KMID : 1011120200140010045
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Bioethics Policy Studies
2020 Volume.14 No. 1 p.45 ~ p.74
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Fast-Track Review System in the Development of the Drugs and Vaccines for Treating Coronavirus Disease
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Park Jee-Hye
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Abstract
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With the advent of the Corona 19 virus, Pharmaceutical industry around the world are going all out to develop treatments and medicines. The rapid development of medicines requires the cooperation of pharmaceutical companies and regulatory agency. From the early stage of development, a legal basis is needed for pharmaceutical companies and regulatory agency to establish and proceed with the plan together. In this paper, we will examine the laws basing on the domestic and foreign Fast-track system. According to this analysis, I would suggest the problems and the direction of improvement of this system. The domestic Fast-track system stipulates the basic details of conditional approval and accelerated approval in 「Regulation for Pharmaceutical Approvals, Notifications and Reviews」 and 「Regulations on Approval and Review of Biological Products」etc., which fall under the notification of the Ministry of Food and Drug Safety. 「The Safety and Support for Regenerative Medicine and Biopharmaceutical Medicine Advanced Therapy Act」 provides for Breakthrough Therapy, Priority Review, Accelerated Approval in the case of Biopharmaceutical Medicine Advanced Therapy. In the case of medicines aimed at treating and preventing infectious diseases, 「Infectious Diseases Control and Prevention Act」 does not provide a separate rapid examination system, there is a problem that the possibility of expedited reviews depends on the characteristics of molecular structure of the drug. There is also a risk of creating confusion because different laws and regulations use different terms, even if they are substantially the same procedure. Therefore, it will be necessary to overhaul the unified legal system for the quick review system in the future. Through these improvements, we hope that the development of new drugs in Korea will be more active.
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KEYWORD
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COVID-19, expedited reviews, Fast Track, drug approval, vaccine, biopharmaceutical, priority reviews
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